The objective of this study is to evaluate efficacy and safety of initial combination therapy with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment naïve patients with type 2 diabetes, In other words, to proof superiority of initial combination therapy with Gemigliptin and Metformin than each monotherapy.

Patients with hemoglobin A1c (HbA1c) over 7.5% at Visit1(screening) and no previous antidiabetic drugs before Visit 1(screening) or patients with hemoglobin A1c (HbA1c) between 7%~10.5%, Patients treated with metformin monotherapy before Visit 1(screening).

Patients with no previous antidiabetic drugs

Patients with hemoglobin A1c (HbA1c) between 7.5%~11% at Visit 2(randomization)

Patients who were treated with Anti-obesity drugs in the last 12 weeks prior to Visit 1(screening)

Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or in the last 6 months prior to Visit 1.

Patients who had experienced myocardial infarction, unstable angina or prior history of coronary artery bypass surgery within 6 months prior to Visit1(screening), or patients with arrhythmia requiring treatment

Patients with history of addiction to alcohol or drugs within 1year prior to Visit 1(screening).

Patients with history of Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.

Patients with history of hypersensitivity to gemiglpitin or Dipeptidyl-peptidase4(DPP4) inhibitors.

Patients with history of hypersensitivity to metformin or biguanides.

Patients with history of hypersensitivity to Pioglitazone HCl or Thiazolidinediones

Patients who participated in other clinical trial within 3 months prior to Visit1(screening).

Patients with other reasons who the investigator decided not to be eligible for the study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787396